Systems and methods for visualizing fluid enhanced ablation therapy

ABSTRACT

Systems and methods for visualizing fluid enhanced ablation therapy are described herein. In one embodiment, a method for ablating tissue is provided that includes inserting an elongate body into a tissue volume, heating an imageable fluid within the elongate body to transform the imageable fluid into an imageable therapeutic fluid, delivering the imageable therapeutic fluid into the tissue volume to deliver a therapeutic dose of thermal energy to the tissue volume, and imaging the tissue volume to determine the extent of the tissue volume containing the imageable therapeutic fluid. The imageable therapeutic fluid can indicate the extent of the tissue volume that has received the therapeutic dose of thermal energy.

CROSS REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of U.S. patent applicationSer. No. 13/842,561, filed on Mar. 15, 2013, entitled “Systems AndMethods For Visualizing Fluid Enhanced Ablation Therapy,” the entirecontents of which is hereby incorporated herein by reference.

FIELD

The present invention relates generally to fluid enhanced ablationtherapy, and more particularly, to systems and methods for visualizingthe flow of fluid introduced during fluid enhanced ablation therapy.

BACKGROUND

Fluid enhanced ablation therapy involves the introduction of a fluidinto a volume of tissue to deliver a therapeutic dose of energy in orderto destroy tissue. The fluid can act as a therapeutic agent deliveringthermal energy into the tissue volume—thermal energy supplied from thefluid itself (e.g., a heated fluid) or from an ablation element thatprovides thermal energy using, e.g., radio frequency (RF) electricalenergy, microwave or light wave electromagnetic energy, ultrasonicvibrational energy, etc. This therapy can be applied to a variety ofprocedures, including the destruction of tumors.

One example of fluid enhanced ablation therapy is the SERF™ ablationtechnique (Saline Enhanced Radio Frequency™ ablation) described in U.S.Pat. No. 6,328,735, which is hereby incorporated by reference in itsentirety. Using the SERF ablation technique, saline is passed through aneedle and heated, and the heated fluid is delivered into a targetvolume of tissue surrounding the needle. In addition, RF electricalcurrent is simultaneously passed through the tissue between an emitterelectrode positioned on the needle and a remotely located returnelectrode. The saline acts as a therapeutic agent to deliver its thermalenergy to the target volume of tissue via convection, and the RFelectrical energy can act to supplement and/or replenish the thermalenergy of the fluid that is lost as it moves through the tissue. Thedelivery of thermal energy via the movement of fluid through tissue canallow a greater volume of tissue to be treated with a therapeutic doseof ablative energy than is possible with other known techniques. Thetherapy is usually completed once the target volume of tissue reaches adesired therapeutic temperature, or otherwise receives a therapeuticdose of energy.

A common challenge in fluid enhanced ablation therapy is determining theextent of the target volume of tissue that has received a therapeuticdose of thermal energy. Known techniques for monitoring therapy progressinclude measuring the temperature of various portions of the targetvolume of tissue directly. Exemplary devices and methods for conductingsuch monitoring are described in U.S. Pat. Pub. No. 2012/0277737, whichis hereby incorporated by reference in its entirety.

However, measuring the temperature of various portions of the targetvolume of tissue is not necessarily an effective technique formonitoring therapy progress. This is because it is often impractical toinclude more than a few temperature sensors on a single device, and thesensors can only report the temperature of the target volume of tissuein their immediate location. As a result, it can be difficult to monitorthe overall shape of the treated volume of tissue.

Still further, misplacement of the needle or other fluid introductiondevice, or adjacent anatomical features that have high blood flow (e.g.,capillaries, veins, etc.) can result in undesired and unexpected fluidflow. This unexpected fluid flow can direct therapeutic energy in anunexpected manner, thereby altering the shape and size of the treatedvolume of tissue that has received a therapeutic dose of thermal energy.Techniques for remotely monitoring the temperature of the target volumeof tissue can report that the temperature is not rising as expected, butmay not show where the heated fluid is flowing to and what the alteredtreated volume of tissue looks like.

Accordingly, there is a need in the art for improved systems and methodsfor monitoring fluid enhanced ablation therapy.

SUMMARY

The present invention generally provides systems and methods fordirectly visualizing fluid enhanced ablation therapy. The systems andmethods described herein generally include visualizing the flow of animageable therapeutic fluid in a fluid enhanced ablation therapyprocedure and correlating the visualized fluid flow with the shape andsize of a volume of tissue that has received a therapeutic dose ofthermal energy. In some cases, the imageable therapeutic fluid can be,e.g., a heated mix of one or more fluids (e.g., saline) that includes acontrast agent that can be used to visualize the flow of the therapeuticfluid. The visualized fluid flow can in some cases directly indicate thevolume of tissue that has received a therapeutic dose of thermal energyor, in other cases, can indicate that a certain portion of the volume oftissue has received a therapeutic dose of thermal energy.

In one aspect, a method for ablating tissue is provided that includesinserting an elongate body into a tissue volume, heating an imageablefluid within the elongate body to transform the imageable fluid into animageable therapeutic fluid, delivering the imageable therapeutic fluidinto the tissue volume to deliver a therapeutic dose of thermal energyto the tissue volume, and imaging the tissue volume to determine theextent of the tissue volume containing the imageable therapeutic fluid.The imageable therapeutic fluid can indicate the extent of the tissuevolume that has received the therapeutic dose of thermal energy.

In another embodiment, the method can include inserting an elongate bodyhaving an ablation element disposed thereon into a tissue volume. Themethod can further include heating an imageable fluid within theelongate body to transform the imageable fluid into an imageabletherapeutic fluid, and delivering energy to the ablation element on theelongate body. The energy and the imageable therapeutic fluid can besimultaneously delivered into the volume of tissue to deliver atherapeutic dose of thermal energy to the tissue volume. The method canfurther include imaging the tissue volume to determine the extent of thetissue volume containing the imageable therapeutic fluid, wherein theimageable therapeutic fluid can indicate the extent of the tissue volumethat has received the therapeutic dose of thermal energy.

The systems and methods described herein can have a number of additionalfeatures and/or modifications, all of which are considered within thescope of the present invention. For example, a variety of fluids can beused in the systems and methods described herein. In certainembodiments, the imageable fluid can include saline and a contrast agentto aid in visualizing the flow of the imageable fluid. The saline andcontrast agent can be mixed together in a variety of proportions, eitherprior to use or instantaneously as the imageable fluid is delivered tothe elongate body. In some embodiments, a ratio of saline to contrastagent can be about 1:1. In other embodiments, the ratio of saline tocontrast agent can be about 10:1, while in still other embodiments theratio of saline to contrast agent can be about 20:1. A number ofdifferent contrast agents can be employed with the systems and methodsof the present invention, so long as they do not adversely impact thesafety or effectiveness of the therapy procedure, as described in moredetail below. In some embodiments, the contrast agent can be a watersoluble contrast agent, and more preferably an iodinated water solublecontrast agent, such as iohexol.

In some embodiments, it can be important for the imageable therapeuticfluid utilized to have a heat capacity that is close to, or greaterthan, the heat capacity of the tissue itself. The imageable therapeuticfluid can act by exchanging thermal energy with tissue, therefore usinga fluid with a heat capacity close to, or greater than, the heatcapacity of the tissue can ensure that the imageable therapeutic fluiddoes not excessively lose its stored energy to the tissue as it heatsthe tissue. In some embodiments, for example, a heat capacity of theimageable therapeutic fluid can be greater than about 2 J/ml-° C., andmore preferably greater than about 4 J/ml-° C.

A variety of different medical imaging technologies can be utilized toimage the tissue volume to determine the extent of the tissue volumecontaining the imageable fluid. In some embodiments, for example, thetissue volume can be imaged using fluoroscopy, computed tomography (CT)scan, computer axial tomography (CAT) scan, magnetic resonance imaging(MRI), or ultrasound. The medical imaging technology utilized can, insome embodiments, be selected based on the contrast agent used in theimageable therapeutic fluid. For example, if iohexol is used as thecontrast agent, the tissue can be imaged using computed tomography (CT)scanning, fluoroscopy, or some other form of X-ray imaging that issensitive to iohexol.

Heating of the imageable fluid can be accomplished in a variety ofmanners. In certain embodiments, the imageable fluid can be heated by aheating element disposed within the elongate body. A number of differentheating elements can be employed, including radio frequency (RF), laser,microwave, and resistive electrical heating elements. Further details onexemplary heating elements that can be used in the systems and methodsdescribed herein can be found in U.S. Pat. Pub. No. 2012/0265190, whichis hereby incorporated by reference in its entirety.

As mentioned above, the visualized fluid flow in the tissue volume canindicate the extent of the tissue volume that has received thetherapeutic dose of thermal energy. In some embodiments, a ratio of alinear dimension of a portion of the tissue volume containing theimageable therapeutic fluid to a linear dimension of a portion of thetissue volume that has received the therapeutic dose of thermal energycan be about 1:1. That is, the visualized fluid flow can directlycorrelate to the size of the treated volume of tissue. However, thecorrelation between the portion of the tissue volume containing theimageable therapeutic fluid to the portion of the tissue volume that hasbeen treated need not be 1:1. For example, in some embodiments, a ratioof a linear dimension of a portion of the tissue volume containing theimageable therapeutic fluid to a linear dimension of a portion of thetissue volume that has received the therapeutic dose of thermal energycan be about 3:2. In other embodiments, a ratio of a linear dimension ofa portion of the tissue volume containing the imageable therapeuticfluid to a linear dimension of a portion of the tissue volume that hasreceived the therapeutic dose of thermal energy can be about 2:1. Instill other embodiments, a ratio of a linear dimension of a portion ofthe tissue volume containing the imageable therapeutic fluid to a lineardimension of a portion of the tissue volume that has received thetherapeutic dose of thermal energy can be about 5:1. Still further, insome embodiments, a ratio of a linear dimension of a portion of thetissue volume containing the imageable therapeutic fluid to a lineardimension of a portion of the tissue volume that has received thetherapeutic dose of thermal energy can be about 10:1.

In certain embodiments, the relationship between the size of a portionof the tissue volume containing the imageable therapeutic fluid and thesize of a portion of the tissue volume that has received a therapeuticdose of thermal energy can be described by a mathematical relationship.In some embodiments, for example, the method can include evaluating amathematical model using a dimension of the imaged tissue volumecontaining the imageable therapeutic fluid to determine a dimension ofthe tissue volume that has received the therapeutic dose of thermalenergy. In other embodiments, a ratio between the dimension of thetissue volume that has received the therapeutic dose of thermal energycalculated by the mathematical model and the dimension of the imagedtissue volume containing the imageable therapeutic fluid can be about2:3. Of course, this calculated value can vary based on the mathematicalmodel derived from, for example, the therapy operating parameters,tissue type, size and shape of the tissue volume, nearby sources ofblood flow, etc.

The ablation element disposed on the elongate body can utilize a varietyof types of therapeutic energy. For example, in some embodiments theablation element can include a source of electromagnetic energy.Exemplary sources of electromagnetic energy can include, in variousembodiments, RF electrical energy, laser light energy, and microwaveelectrical energy. In other embodiments, the ablation element caninclude a source of ultrasonic energy.

In another aspect, a system for delivering fluid enhanced ablationtherapy is provided that includes an elongate body having proximal anddistal ends, an inner lumen extending through the elongate body, atleast one outlet port formed in the elongate body, and at least oneablation element positioned along the length of a distal portion of theelongate body. The system can further include an imageable fluid sourcein communication with the inner lumen of the elongate body, theimageable fluid source including saline and a contrast agent. The systemcan further include a heating element disposed within the inner lumen ofthe elongate body and configured to heat the imageable fluid totransform the imageable fluid into an imageable therapeutic fluid thatcan flow through the at least one outlet port and be delivered to tissuesurrounding the at least one ablation element.

All of the variations and modifications discussed above can be includedin a system according to the teachings of the present invention. Forexample, in some embodiments a heat capacity of the imageable fluid canbe greater than about 2 J/ml-° C., and more preferably greater thanabout 4 J/ml-° C. In other embodiments, a ratio of saline to contrastagent can be about 1:1. In still other embodiments, a ratio of saline tocontrast agent can be about 10:1. In yet other embodiments, a ratio ofsaline to contrast agent can be about 20:1. Furthermore, a variety ofcontrast agents can be used in the imageable fluid. In some embodiments,the contrast agent can be iohexol.

The ablation element positioned along the length of a distal portion ofthe elongate body can be configured to deliver a variety of types ofenergy into the tissue surrounding the elongate body. For example, insome embodiments, the ablation element can be configured to deliverenergy selected from the group consisting of electromagnetic energy,radio frequency energy, laser energy, microwave energy, and ultrasonicenergy.

The systems and methods described herein can provide a number ofadvantages over prior art systems and methods for monitoring fluidenhanced ablation therapy. In particular, the systems and methodsdescribed herein can allow for the direct visualization of the flow ofan imageable therapeutic fluid as it delivers thermal energy within atarget tissue volume. The expansion over time of a portion of the tissuevolume containing the imageable therapeutic fluid can be monitored toensure that fluid is not flowing in an undesirable or unexpected manner,and the size of the portion of the tissue volume containing thevisualized therapeutic fluid can be used to indicate the size of theportion of the tissue volume that has received a therapeutic dose ofthermal energy. Accordingly, the systems and methods described hereincan provide a far more robust and detailed view of the progress of afluid enhanced ablation therapy procedure.

BRIEF DESCRIPTION OF THE DRAWINGS

The aspects and embodiments of the invention described above will bemore fully understood from the following detailed description taken inconjunction with the accompanying drawings, in which:

FIG. 1 is a diagram of one embodiment of a fluid enhanced ablationtherapy system;

FIG. 2 is a perspective view of one embodiment of a medical devicehaving an elongate body for use in fluid enhanced ablation therapy;

FIG. 3A is a fluoroscopic X-ray image of a fluid enhanced ablationtherapy device disposed in a heart prior to therapy;

FIG. 3B is an fluoroscopic X-ray image of the fluid enhanced ablationtherapy device of FIG. 3A during therapy;

FIG. 4 is an image of the heart of FIGS. 3A-3B after therapy;

FIG. 5 is an alternative embodiment of a fluid enhanced ablation therapysystem;

FIG. 6 is a graphical representation of simulated fluid enhancedablation therapy heating profiles over time; and

FIG. 7 is a graphical representation of simulated expansion over time ofa proportion of a tissue volume that contains contrast agent and aproportion of the tissue volume that has received a therapeutic dose ofthermal energy.

DETAILED DESCRIPTION

Certain exemplary embodiments will now be described to provide anoverall understanding of the principles of the systems and methodsdisclosed herein. One or more examples of these embodiments areillustrated in the accompanying drawings. Those skilled in the art willunderstand that the systems and methods specifically described hereinand illustrated in the accompanying drawings are non-limiting exemplaryembodiments and that the scope of the present invention is definedsolely by the claims. The features illustrated or described inconnection with one exemplary embodiment may be combined with thefeatures of other embodiments. Such modifications and variations areintended to be included within the scope of the present invention.

The present invention is generally directed to systems and methods forvisualizing fluid enhanced ablation therapy and, in particular, tosystems and methods for visualizing the expansion over time of aproportion of a volume of tissue that has received a therapeutic dose ofthermal energy (i.e., visualizing the expansion of a therapeutictemperature front as it encompasses a greater volume of tissue overtime). The systems and methods described herein generally includevisualizing the flow of an imageable therapeutic fluid in a fluidenhanced ablation therapy procedure and correlating the visualized flowwith the shape and size of a volume of tissue that has received atherapeutic dose of thermal energy. In some cases, the imageabletherapeutic fluid can be, e.g., a heated mix of saline and a contrastagent that can aid in visualizing the flow of the therapeutic fluid. Thevisualized fluid can in some cases directly indicate the volume oftissue that has received a therapeutic dose of thermal energy or, inother cases, can indicate that a certain portion of the volume of tissuecontaining the imageable therapeutic fluid has received a therapeuticdose of thermal energy. The systems and methods described herein provideunique advantages over known methods for monitoring fluid enhancedablation therapy, including, for example, the ability to directlyvisualize the flow of an imageable therapeutic fluid within a patient'sbody to monitor the progress of a therapeutic procedure.

Fluid enhanced ablation therapy, as mentioned above, is defined bypassing a fluid into tissue to act as a therapeutic agent and deliverthermal energy into the tissue. The thermal energy can be provided fromthe fluid itself (e.g., by using heated fluid), by deliveringtherapeutic energy from an ablation element (e.g., an RF electrode), ora combination of the two. The delivery of therapeutic energy into tissuecauses hyperthermia in the tissue, ultimately resulting in necrosis.This temperature-induced selective destruction of tissue can be utilizedto treat a variety of conditions including tumors, fibroids, cardiacdysrhythmias (e.g., ventricular tachycardia, etc.), and others.

The SERF™ ablation technique (Saline Enhanced Radio Frequency™ ablation)described in U.S. Pat. No. 6,328,735 and incorporated by referenceabove, delivers fluid heated to a therapeutic temperature into tissuealong with ablative energy. The heated fluid acts as a therapeutic agentby flowing through the extracellular space of the treatment tissue andincreasing the heat transfer through the tissue significantly. Inparticular, the flowing heated fluid convects thermal energy into thetarget tissue. The thermal energy can be supplied from the heated fluiditself, and the ablation energy source can act to replenish thermalenergy lost from the fluid as it moves through tissue. Furthermore, thefluid can serve to constantly hydrate the tissue and prevent any tissuecharring and associated impedance rise near the ablation element, asdescribed in more detail below.

Fluid enhanced ablation therapy can have a number of advantages overprior art ablation techniques, such as conventional RF ablation. Forexample, conventional RF ablation often overheats the tissue locatedadjacent to the emitter electrode because the heat cannot be efficientlytransported away from the electrode. This overheating can cause charringof the tissue and an associated rise in impedance that can effectivelyterminate the therapy. During fluid enhanced ablation therapy, incontrast, the therapeutically heated fluid can convect heat deeper intothe target tissue, thereby reducing tissue charring and the associatedimpedance change of the tissue. Further, because the fluid is heated toa therapeutic level, it does not act as a heat sink that draws down thetemperature of the surrounding tissue. Instead, the fluid itself acts asthe therapeutic agent delivering thermal energy into the tissue and theRF energy can act to counter the loss of thermal energy from the fluidas it moves through the tissue. Therefore, the concurrent application ofRF energy and injection of heated fluid into the tissue can eliminatethe desiccation and/or vaporization of tissue adjacent to the electrode,maintain the effective tissue impedance, and increase the thermaltransport within the tissue being heated with RF energy. The totalvolume of tissue that can be heated to therapeutic temperatures isthereby increased when compared to, e.g., conventional RF ablation.

In addition, fluid enhanced ablation therapy devices have a greaternumber of parameters that can be varied to adjust the shape of thetreated volume of tissue. For example, when using the SERF ablationtechnique, an operator or control system can modify parameters such asfluid temperature (e.g., from about 40° C. to about 80° C.), fluid flowrate (e.g., from about 0 ml/min to about 20 ml/min), RF power (e.g.,from about 0 W to about 100 W), and duration of treatment (e.g., fromabout 0 min to about 10 min) to adjust the temperature profile withinthe target volume of tissue. Different electrode configurations can alsobe used to vary the treatment. For example, an emitter electrode can beconfigured as a continuous cylindrical band around a needle or otherelongate body, or the electrode can be formed in other geometries, suchas spherical or helical. The electrode can form a continuous surfacearea, or it can have a plurality of discrete portions.

FIG. 1 illustrates a diagram of one embodiment of a fluid enhancedablation system 100. The system includes an elongate body 102 configuredfor insertion into a target volume of tissue. The elongate body can havea variety of shapes and sizes according to the geometry of the targettissue. Further, the particular size of the elongate body can depend ona variety of factors including the type and location of tissue to betreated, the size of the tissue volume to be treated, etc. By way ofexample only, in one embodiment, the elongate body can be a thin-walledstainless steel needle between about 16- and about 18-gauge (i.e., anouter diameter of about 1.27 mm to about 1.65 mm), and having a length L(e.g., as shown in FIG. 2) that is approximately 25 cm. The elongatebody 102 can include a pointed distal tip 104 configured to puncturetissue to facilitate introduction of the device into a target volume oftissue, however, in other embodiments the tip can be blunt and can havevarious other configurations. The elongate body 102 can be formed from aconductive material such that the elongate body can conduct electricalenergy along its length to one or more ablation elements located along adistal portion of the elongate body. Mono-polar emitter electrode 105 isan example of an ablation element capable of delivering RF energy fromthe elongate body.

In some embodiments, the emitter electrode 105 can be a portion of theelongate body 102. For example, the elongate body 102 can be coated inan insulating material along its entire length except for the portionrepresenting the emitter electrode 105. More particularly, in oneembodiment, the elongate body 102 can be coated with 1.5 mil of thefluoropolymer Xylan™ 8840. In other embodiments, different coatings canbe used in place of, or in conjunction with, the fluoropolymer coating.For example, in certain embodiments, 1 mil of Polyester shrink tubingcan be disposed over the Xylan coating. The electrode 105 can have avariety of lengths and shape configurations. In one embodiment, theelectrode 105 can be a 4 mm section of a tubular elongate body that isexposed to surrounding tissue. Further, the electrode 105 can be locatedanywhere along the length of the elongate body 105 (and there can alsobe more than one electrode disposed along the length of the elongatebody). In one embodiment, the electrode can be located adjacent to thedistal tip 104. In other embodiments, the elongate body can be formedfrom an insulating material, and the electrode can be disposed aroundthe elongate body or between portions of the elongate body.

In other embodiments, the electrode can be formed from a variety ofother materials suitable for conducting current. Any metal or metal saltmay be used. Aside from stainless steel, exemplary metals includeplatinum, gold, or silver, and exemplary metal salts includesilver/silver chloride. In one embodiment, the electrode can be formedfrom silver/silver chloride. It is known that metal electrodes assume avoltage potential different from that of surrounding tissue and/orliquid. Passing a current through this voltage difference can result inenergy dissipation at the electrode/tissue interface, which canexacerbate excessive heating of the tissue near the electrodes. Oneadvantage of using a metal salt such as silver/silver chloride is thatit has a high exchange current density. As a result, a large amount ofcurrent can be passed through such an electrode into tissue with only asmall voltage drop, thereby minimizing energy dissipation at thisinterface. Thus, an electrode formed from a metal salt such assilver/silver chloride can reduce excessive energy generation at thetissue interface and thereby produce a more desirable therapeutictemperature profile, even where there is no liquid flow about theelectrode.

The electrode 105 or other ablation element can include one or moreoutlet ports 108 that are configured to deliver fluid from an innerlumen 106 extending through the elongate body 102 into surroundingtissue (as shown by arrows 109). Alternatively, the electrode 105 can bepositioned near one or more outlet ports 108 formed in the elongate body102. In many embodiments, it can be desirable to position the electrodeadjacent to the one or more outlet ports to maximize the effect of theflowing fluid on the therapy. The outlet ports 108 can be formed in avariety of sizes, numbers, and pattern configurations. In addition, theoutlet ports 108 can be configured to direct fluid in a variety ofdirections with respect to the elongate body 102. These can include thenormal orientation (i.e., perpendicular to the elongate body surface)shown by arrows 109, as well as orientations directed proximally anddistally along a longitudinal axis of the elongate body 102, includingvarious orientations that develop a circular or spiral flow of liquidaround the elongate body. Still further, in some embodiments, theelongate body 102 can be formed with an open distal end that serves asan outlet port. By way of example, in one embodiment, twenty-fourequally-spaced outlet ports 108 having a diameter of about 0.4 mm can becreated around the circumference of the electrode 105 using ElectricalDischarge Machining (EDM). One skilled in the art will appreciate thatadditional manufacturing methods are available to create the outletports 108. In addition, in some embodiments, the outlet ports can bedisposed along a portion of the elongate body adjacent to the electrode,rather than being disposed in the electrode itself.

The inner lumen 106 that communicates with the outlet ports 108 can alsohouse a heating assembly 110 configured to heat fluid as it passesthrough the inner lumen 106 just prior to being introduced into tissue.The heating assembly 110 can have a variety of configurations and, inone embodiment, can include two wires suspended within the inner lumen106. The wires can be configured to pass RF energy therebetween in orderto heat fluid flowing through the inner lumen 106. In other embodiments,a single wire can be configured to pass RF energy between the wire andthe inner walls of the elongate body. Further description of exemplaryheating assemblies can be found in U.S. Pat. Pub. No. 2012/0265190,which is incorporated by reference above.

The portion of the elongate body located distal to the electrode 105 orother ablation element can be solid or filled such that the inner lumen106 terminates at the distal end of the electrode 105. In oneembodiment, the inner volume of the portion of the elongate body distalto the electrode can be filled with a plastic plug that can be epoxiedin place or held by an interference fit. In other embodiments, theportion of the elongate body distal to the electrode can be formed fromsolid metal and attached to the proximal portion of the elongate body bywelding, swaging, or any other technique known in the art.

The elongate body 102 illustrated in FIG. 1 can be configured forinsertion into a patient's body in a variety of manners. FIG. 2illustrates one embodiment of a medical device 200 having an elongatebody 202 coupled to a distal end thereof and configured for laparoscopicor direct insertion into a target area of tissue. In addition to theelongate body 202, the device 200 includes a handle 204 to allow anoperator to manipulate the device. The handle 204 includes one or moreelectrical connections 206 that connect various components of theelongate body (e.g., the heating assembly and ablation element 205) to,for example, the controller 118 shown in FIG. 1. The handle 204 alsoincludes at least one fluid conduit 208 for connecting a fluid source tothe device 200.

While the device 200 is one exemplary embodiment of a medical devicethat can be adapted for use in fluid enhanced ablation therapy, a numberof other devices can also be employed. For example, a very smallelongate body can be required in treating cardiac dysrhythmias, such asventricular tachycardia. In such a case, an appropriately sized elongateneedle body can be, for example, disposed at a distal end of a catheterconfigured for insertion into the heart via the circulatory system. Inone embodiment, a stainless steel needle body between about 20- andabout 30-gauge (i.e., an outer diameter of about 0.3 mm to about 0.9 mm)can be disposed at a distal end of a catheter. The catheter can have avariety of sizes but, in some embodiments, it can have a length of about120 cm and a diameter of about 8 French (“French” is a unit of measureused in the catheter industry to describe the size of a catheter and isequal to three times the diameter of the catheter in millimeters).

Referring back to FIG. 1, an exemplary fluid source is shown as a fluidreservoir 112. The fluid reservoir 112 can have a variety of geometriesand sizes. In one embodiment, the fluid reservoir 112 can be acylindrical container similar to a syringe barrel that can be used witha linear pump, as described below. The fluid reservoir 112 can beconnected to the inner lumen 106 via a fluid conduit 114 to supply fluidto the inner lumen and heating assembly 110. The fluid conduit 114 canbe, for example, a length of flexible plastic tubing. The fluid conduit114 can also be a rigid tube, or a combination of rigid and flexibletubing. A fluid used in the fluid reservoir 112 can be selected toprovide the desired therapeutic and physical properties when applied tothe target tissue, and a sterile fluid is recommended to guard againstinfection of the tissue. A preferred fluid for use in the SERF ablationtechnique is sterile normal saline solution (defined as asalt-containing solution). In the systems and methods described herein,an imageable fluid can be utilized and transformed into an imageabletherapeutic fluid by heating the imageable fluid within the elongatebody 102. An exemplary imageable fluid can include saline and a contrastagent to aid in visualizing the fluid. Regardless of what particularfluid is utilized, it can be important for the imageable therapeuticfluid to have a heat capacity that is equal to or greater than about ½of the heat capacity of tissue to be treated during therapy. In oneembodiment, the imageable therapeutic fluid can have a heat capacitythat is equal to or great than about 2 J/ml-° C., and more preferablyabout 4 J/ml-° C. This is so the fluid can maintain its therapeuticeffect as it exchanges thermal energy with the tissue. In someembodiments, for example, the contrast agent can be selected such thatit does not significantly alter the heat capacity of the overall fluid(e.g., the contrast agent and saline) so as to maintain the therapeuticabilities of the imageable fluid.

Fluid can be urged from the fluid reservoir 112 into the inner lumen 106by a pump 116. In one embodiment, the pump 116 can be a syringe-typepump that produces a fixed volume flow via linear advancement of aplunger (not shown). In other embodiments, however, other types ofpumps, such as a diaphragm pump, may also be employed.

The pump 116, as well as any other components of the system, can becontrolled by a controller 118. The controller 118 can include a powersupply 119 and can be configured to deliver electrical control signalsto the pump 116 to cause the pump to produce a desired flow rate offluid. The controller 118 can be connected to the pump 116 via anelectrical connection 120. The controller 118 can also include aninterface for receiving lead wires or other connecting elements toelectrically couple the controller 118 to the elongate body 102 and oneor more return electrodes 124. These electrical connections, which canhave any desired length and can utilize any known electrical connectingelements to interface with the controller 118 (e.g., plugs, alligatorclips, rings, prongs, etc.), are illustrated in FIG. 1 as connections122 and 126. In addition, the controller 118 can be connected to theheating assembly 110 through a similar electrical connection, asdescribed below.

The return electrode 124 can have a variety of forms. For example, thereturn electrode 124 can be a single large electrode located outside apatient's body. In other embodiments, the return electrode 124 can be areturn electrode located elsewhere along the elongate body 102, or itcan be located on a second elongate body introduced into a patient'sbody near the treatment site. Regardless of the configuration used, thereturn electrode 124 is designed to receive current emitted from themono-polar ablation element 105, thereby completing the circuit back tothe controller 118 through the electrical connection 126.

In operation, the controller 118 can drive the delivery of fluid intotarget tissue at a desired flow rate, the heating of the imageable fluidto a desired therapeutic temperature, and the delivery of therapeuticablative energy via the one or more ablation elements, such as electrode105. To do so, the controller 118 can itself comprise a number ofcomponents for generating, regulating, and delivering requiredelectrical control and therapeutic energy signals. In addition to thepower supply 119 mentioned above, the controller 118 can include one ormore digital data processors and associated storage memories that can beconfigured to perform a variety of functions, or control discretecircuit elements that perform a given function. These functions caninclude, for example, the generation of one or more electrical signalsof various frequencies and amplitudes. Furthermore, the controller 118can be configured to amplify any of these signals using one or more RFpower amplifiers into relatively high-voltage, high-amperage signals,e.g., 50 volts at 1 amp. These RF signals can be delivered to theablation element 105 via one or more electrical connections 122 and theelongate body 102 such that RF energy is passed between the emitterelectrode 105 and any return electrodes or electrode assemblies 124 thatare located remotely on a patient's body. In embodiments in which theelongate body is formed from non-conductive material, the one or moreelectrical connections 122 can extend through the inner lumen of theelongate body or along its outer surface to deliver current to theemitter electrode 105. The passage of RF energy between the ablationelement and the return electrode 124 can heat the imageable therapeuticfluid and tissue surrounding the elongate body 102 due to their inherentelectrical resistivity. The controller 118 can also include a number ofother components, such as a directional coupler to feed a portion of theone or more RF signals to, for example, a power monitor to permitadjustment of the RF signal power to a desired treatment level. Stillfurther, the controller 118 can include a user interface 121 to allow anoperator to interact with the controller and set desired therapyoperating parameters or receive feedback from the controller (e.g.,warnings, indications, etc.).

As mentioned above, one challenge in fluid enhanced ablation therapy ismonitoring the progress of the therapy. The ability to visualize theflow of a therapeutic fluid within a patient's body can be important forseveral reasons. For example, visualizing the flow can provide anindication of how much of a target tissue volume has received, or islikely to have received, a therapeutic dose of thermal energy from thetreatment therapy. In addition, visualizing the flow of such a fluid canbe helpful for an operator to determine if the elongate body iscorrectly positioned within a patient's body and whether or not thefluid is flowing within the target treatment volume in an expectedmanner.

Prior art techniques for monitoring the progress of fluid enhancedablation therapy largely focus on measuring the temperature of tissue atspecific points within the target tissue volume. Exemplary embodimentsof such techniques are described in U.S. Pat. Pub. No. 2012/0277737,incorporated by reference above. Measuring the temperature of specificlocations within a target tissue volume is not necessarily an effectiveindication of therapy process. In particular, sensors report only thetemperature at their specific location, and do not provide informationon the development of the volume of treated tissue as a whole. Inaddition, in the event that unexpected fluid flow is encountered (e.g.,due to an adjacent vein or other anatomical feature that draws fluidaway from the target tissue volume), remote temperature sensors mightnot provide any meaningful information other than the absence of anincrease in temperature within the target tissue volume.

The systems and methods of the present invention address thesechallenges by providing for the direct visualization of the flow of atherapeutic fluid within a patient's body. This is accomplished by usingan imageable fluid that can be viewed using any of a variety of knownmedical imaging technologies including, for example, fluoroscopy,computed tomography (CT) scanning, computer axial tomography (CAT)scanning, magnetic resonance imaging (MRI), and ultrasound. Furthermore,the systems and methods described herein allow for the determination ofthe size of a tissue volume that has received a therapeutic dose ofthermal energy based on the size of a tissue volume that contains theimageable therapeutic fluid. The relationship between the sizes of thesetissue volumes can be 1:1, or some other value based on the tissue typeand therapy parameters in use, as described in more detail below.

In one aspect, for example, a method for ablating tissue is providedthat includes inserting into a tissue volume an elongate body having anablation element disposed thereon. The method can further includeheating an imageable fluid within the elongate body to transform theimageable fluid into an imageable therapeutic fluid, and deliveringenergy to the ablation element on the elongate body. The energy and theimageable therapeutic fluid can be simultaneously delivered into thevolume of tissue to deliver a therapeutic dose of thermal energy. Themethod can further include imaging the tissue volume to determine theextent of the tissue volume containing the imageable therapeutic fluid,wherein the imageable therapeutic fluid indicates the extent of thetissue volume that has received the therapeutic dose of thermal energy.

FIGS. 3A-3B illustrate one embodiment of such a method. FIG. 3A, inparticular, is an X-ray image of a heart 300 taken prior to thecommencement of fluid enhanced ablation therapy. Visible within theheart is a catheter 302 having a needle body disposed at a distal end304 thereof. FIG. 3B is an X-ray image of the heart 300 taken at a pointduring fluid enhanced ablation therapy. Visible in FIG. 3B is animageable therapeutic fluid 306 surrounding and obscuring the distal end304 of the catheter 302. The imageable therapeutic fluid 306 is beingintroduced into the heart 300 from the needle body disposed at thedistal end 304 (not shown in FIG. 3B) of the catheter 302. By monitoringthe heart 300 using X-rays, the imageable therapeutic fluid 306 can bedirectly visualized to determine if the fluid is flowing through thetissue of the heart in an expected manner. Furthermore, the extent ofthe heart tissue containing the imageable therapeutic fluid 306 can beused to indicate the extent of the heart tissue that has received atherapeutic dose of thermal energy.

FIG. 4 illustrates cross-sectional slices of the heart 300 taken aftercompletion of the therapy shown in FIGS. 3A-3B. Visible in the figure isa lesion 402 formed during the fluid enhanced ablation therapyprocedure. The size of the lesion 402 corresponds to the size of theimageable therapeutic fluid 306 visible in FIGS. 3A-3B, as the imageabletherapeutic fluid 306 remained within a treated volume of tissue only,or at least within a volume of tissue that can be correlated with atreated volume of tissue, for a duration of time sufficient to capturean image of where the imageable therapeutic fluid has flowed. Theproperties of the imageable therapeutic fluid used can affect theability of the flow to be visualized. For example, if an imageabletherapeutic fluid includes a contrast agent (or other compound to enablevisualization of the fluid) that has too small of a molecular weight,the fluid can dissipate too quickly in the vasculature or throughout thetissue to provide useful visualization. Conversely, if the contrastagent or other compound has too large of a molecular weight, it can befiltered by the spaces in the extracellular fluid, which can result inthe contrast agent being separated from the other components of theimageable therapeutic fluid. This can effectively make imaging of thetherapeutic fluid impossible.

As described above, different fluids can be used in fluid enhancedablation therapy and, accordingly, the imageable fluid can also includea variety of different fluids. In some embodiments, for example, theimageable fluid can be saline (or one or more other fluids used in placeof saline) in combination with a contrast agent that can aid invisualizing the flow of the fluid. A contrast agent can be any substancethat can be more easily detected using any of a variety of medicalimaging technologies. For example, in the case of fluoroscopy and otherX-ray medical imaging technologies, a contrast agent can be a fluidhaving a higher (e.g., positive) Hounsfield Unit value than the salineor other fluids being used. The Hounsfield Unit is a measurement ofradiodensity in which a higher positive number indicates a greaterability to absorb, e.g., X-rays.

Furthermore, and as described above, a contrast agent can be selectedsuch that the mixture of the contrast agent and other fluids (e.g.,saline) does not have a significantly different heat capacity than theother fluids alone. Still further, the heat capacity of the mixture canbe close to, or greater than, the heat capacity of the tissue to betreated. This can be important because a therapeutic fluid having asignificantly lower heat capacity than the surrounding tissue cannegatively affect the therapy. Accordingly, the imageable components ofthe imageable therapeutic fluid can, in some embodiments, be selectedsuch that they are not filtered within the tissue volume, do notdissipate too rapidly within the tissue volume, do not interfere withthe heating element within the elongate body, and further do notnegatively affect the therapeutic performance of the fluid once intissue.

There are many contrast agents known in the art, but one of ordinaryskill in the art would not think to use them in combination with fluidenhanced ablation therapy for a number of reasons. For example, anycontrast agent used in fluid enhanced ablation must be stable at theelevated therapeutic temperatures encountered during therapy. Many knowncontrast agents are not stable at these elevated temperatures (e.g.,above 40° C.) and actually can become poisonous when raised to suchelevated temperatures. Furthermore, many known contrast agents arenon-ionic substances. This can raise concerns about whether the presenceof the non-ionic contrast agent might interfere with, for example, theconduction of electrical energy between the ablation element and theionic saline, saline solution, or other therapeutic fluid. Still furtherand as mentioned above, many contrast agents are large-moleculesubstances that may not be able to flow through the extracellular spaceof a volume of tissue due to the size of the molecules. If the contrastagent cannot flow with the saline through the extracellular space of thetarget tissue volume, it cannot serve its purpose of aiding to visualizethe flow of fluid through the volume.

The systems and methods of the present invention can make use of anycontrast agent that satisfies the criteria discussed above. One suchcontrast agent utilized in certain embodiments is iohexol, a non-ionicdye that is stable at the elevated temperatures encountered during fluidenhanced ablation therapy, does not negatively affect the transfer ofenergy between the ablation element and the imageable fluid, and has asufficiently small molecular size to pass through the extracellularspace of human tissue. The iohexol can be added directly to the saline,or it can be mixed in solution first prior to being mixed with thesaline. The iohexol contrast solution is commercially available underthe trade name Omnipaque®, manufactured by GE Healthcare. Note thatspreading of a dye contrast agent like iohexol via chemical diffusion isnot generally a concern because diffusion takes much longer thanconvection. As a result, over the time periods typically used in fluidenhanced ablation therapy, it can be assumed that the presence of a dyecontrast agent is due to convective fluid flow, not chemical diffusion.

A suitable contrast agent can be mixed with saline or one or more otherfluids in a variety of ratios. For example, in the embodimentillustrated in FIGS. 3A-3B, the contrast agent iohexol was mixed withsaline in a 1:1 ratio. In other embodiments, however, a ratio betweensaline and a contrast agent can be about 10:1, about 20:1, about 50:1,or even greater. The amount of contrast agent added to saline need onlybe large enough to have the desired effect of enabling the flow of theimageable therapeutic fluid to be viewed when using a medical imagingtechnology. Furthermore, a number of different medical imagingtechnologies can be utilized to visualize the flow of fluid within thetarget tissue volume, and certain of these technologies can require theuse of different contrast agents. For example, suitable medical imagingtechnologies for use in the systems and methods described herein caninclude X-ray imaging, fluoroscopy, computed tomography (CT) scan,computer axial tomography (CAT) scan, magnetic resonance imaging (MRI),and ultrasound, and contrast agents suitable for use with one or more ofthese technologies may not be suitable for use with others.

The contrast agent can be mixed with the saline in a variety of manners.For example, with reference to FIG. 1, in some embodiments the contrastagent can be pre-mixed with the saline or other appropriate fluid withinthe fluid reservoir 112. The quantity of contrast agent can bepre-selected based on the volume of saline present in the fluidreservoir 112, and the fluids can be mixed before use to ensure evendispersion of the contrast agent within the fluid reservoir.

FIG. 5 illustrates an alternative embodiment for introducing a contrastagent into saline or another appropriate fluid during fluid enhancedablation therapy. The system 500 includes all of the same components asthe system 100 of FIG. 1, but further includes a mixer 502 disposedinline with the fluid reservoir 112 and pump 116. The mixer 502 can beconfigured to inject into the fluid flowing through the conduit 114 apredetermined amount of contrast agent such that the desired ratio ofsaline to contrast agent is achieved as the imageable fluid exits theoutlet ports 109 of the elongate body 102. One skilled in the art willappreciate that other mechanisms for introducing a contrast agent into areservoir or flow of liquid are possible and these are also consideredwithin the scope of the invention.

As described above, the systems and methods described herein not onlyprovide for the direct visualization of the extent of a tissue volumecontaining an imageable therapeutic fluid, but also for thedetermination of the extent of the tissue volume that has received atherapeutic dose of thermal energy based on the visualization of thefluid flow. The relationship between the size of the volume of tissuecontaining the imageable therapeutic fluid and the size of the volume oftissue that has received a therapeutic dose of thermal energy can varydepending on a number of factors, including the definition of atherapeutic dose, the therapy operating parameters, the tissue type andother anatomical features, etc. In some embodiments, for example, aratio between a linear dimension of the tissue volume containing theimageable therapeutic fluid and a linear dimension of the tissue volumethat has received the therapeutic dose of thermal energy can be about1:1. This proportion can be approached when the heat capacity of theimageable therapeutic fluid is much greater than that of the tissue. Inother embodiments, however, the ratio can be smaller, indicating thatonly a portion of the volume containing the imageable therapeutic fluidhas received a therapeutic dose of thermal energy. For example, in someembodiments, the ratio between a linear dimension of the tissue volumecontaining the imageable therapeutic fluid and a linear dimension of thetissue volume that has received the therapeutic dose of thermal energycan be about 3:2. In other embodiments, the ratio can be about 2:1,about 5:1, or about 10:1.

There are a number of different methods for calculating a therapeuticthermal dose, and any calculation ultimately depends on the temporalhistory of temperature (i.e., the amount of heating the tissue haspreviously endured) and the type of tissue being heated. Nonetheless,one exemplary suggestion by Nath, S. and Haines, D. E., Prog. Card. Dis.37(4):185-205 (1995) (Nath et al.) is that raising the temperature oftissue to 50° C. for one minute administers a therapeutic dose anddestroys the tissue. FIG. 6 illustrates simulated temperature profilesof a spherical volume of tissue extending away from a centrally-locatedelongate body at various times after the initiation of fluid enhancedablation therapy. To create the simulated profiles shown in FIG. 6, anRF power output of 25 Watts with 10 ml/min flow of 50° C. saline wasassumed.

Using the exemplary 50° C. mark as indicative of delivery of atherapeutic dose, the expansion of the treated volume of tissue can beseen over time. In particular, the first profile 602, taken 8 secondsafter the initiation of therapy, indicates that the volume of tissuethat has received a therapeutic dose of thermal energy extends less than1 cm from the elongate body delivering the heated saline and RF or otherenergy. By 80 seconds after the initiation of therapy, the radius of thetreated tissue volume extends about 1.5 cm from the elongate body, asshown by profile 604. The third profile 606, taken 400 seconds afterinitiating therapy, shows the therapeutic dose has been administered toa volume extending about 2.5 cm from the elongate body. The fourthprofile 608, taken 800 seconds after initiating therapy, indicates thatthe therapeutic dose has been administered to a volume of tissueextending about 3 cm from the elongate body. The final profile 610 showsa steady state temperature profile indicating that over a longer periodof time a treatment volume can grow to extend well over 5 cm from theelongate body.

As mentioned above, the expansion over time of a proportion of a volumeof tissue that contains an imageable therapeutic fluid can be equal toor faster than the expansion of the 50° +C isotherm shown in FIG. 6,depending on a number of different factors. For example, in anembodiment utilizing a contrast agent such as iohexol, it is known thatthe contrast agent will preferentially travel through the extracellularspace and will only slowly enter the cells themselves. The imageabletherapeutic fluid, on the other hand, will exchange thermal energy withboth the extracellular space and the cells themselves. In the liver, forexample, the extracellular space comprises approximately ⅓ of the volumeof tissue in the organ. Accordingly, if a volume of therapeuticallyheated saline is delivered at a flow rate Q for a time t, the imageablefluid can fill a volume V approximately 3 times larger (because ittravels through only ⅓ the space of the saline), but the thermal energywill be exchanged with the entire volume of tissue that the imageabletherapeutic fluid has flowed through. Using this information, incombination with the model used to create the temperature profiles ofFIG. 6, a relationship between a radius of the volume containing theimageable fluid and a radius of the volume that has received atherapeutic dose of thermal energy can be determined.

The radius of the volume of tissue that the imageable therapeutic fluidhas flowed through can be expressed in terms of Qt. To begin, the volumeof tissue that the injected imageable therapeutic fluid has filled, V,is:

V=3Qt   (1)

Further, the imageable radius r is related to the filled volumeaccording to:

V= 4/3πr ³   (2)

The imageable radius r is therefore:

$\begin{matrix}{r = \sqrt[3]{\frac{9}{4\pi}{Qt}}} & (3)\end{matrix}$

This equation can be used to solve for the radius r of a volumecontaining a contrast agent at any time t given a fluid flow rate Q.

Using the therapy parameters for the temperature profiles shown in FIG.6, FIG. 7 plots the expansion over time of the radius of the volumecontaining imageable therapeutic fluid and the radius of the volumehaving received a therapeutic dose of thermal energy. In particular, thedashed line 702 indicates the radius of the volume containing imageabletherapeutic fluid from the initiation of therapy out to approximately800 seconds. The dotted line 704 indicates the radius of the volumehaving received a therapeutic dose of thermal energy over the same timeperiod. As is evident from the figure and can be confirmed using themathematical model developed above, the radius of the volume havingreceived a therapeutic dose of thermal energy is about ⅔ the radius ofthe volume containing imageable therapeutic fluid.

Thus, in this example, a ratio of a linear dimension of the volume oftissue containing imageable therapeutic fluid to a linear dimension ofthe volume of tissue that has received a therapeutic dose of thermalenergy is about 3:2. Of course, this is just one possible ratio based onthe heat capacity of the imageable therapeutic fluid, shape of thetissue volumes, type of tissue being treated, and therapy parameters.The ratios can vary based on differences in any of these parameters, butthe concept remains the same, i.e., the expansion of an imageable fluidcan be visualized and the size of a therapeutically treated volume oftissue can be determined based on the visualization.

Another advantage of the systems and methods described herein is theability for a user to determine if the fluid being introduced into thetarget volume of tissue is flowing in an expected manner. If unexpectedfluid flow is observed, a user can terminate therapy to diagnose thecause, reposition the elongate body, etc. The ability to activelymonitor the development of a treatment volume and the flow of atherapeutic fluid within a patient's body can thus improve the safety offluid enhanced ablation therapy.

For example, there are a number of situations in which incorrectplacement of a needle or other elongate body can result in undesiredfluid flow. In the liver, for example, incorrect placement of anelongate body or use of a high fluid flow rate can cause ahydro-dissection of the liver tissue in which the flowing saline tearsthe tissue apart rather than flow through the extracellular space. Inaddition, it is undesirable for fluid to flow out of the liver into theabdominal space. Each of these undesired phenomena can be directlyvisualized using the systems and methods of the present invention unlikeprior art methods for monitoring fluid flow. Moreover, directvisualization allows for improved speed and accuracy during therapydelivery.

Fluid enhanced ablation therapy is also used commonly in the heart totreat cardiac dysrhythmias, such as ventricular tachycardia. Similar tothe liver, misplacement of the elongate body in the heart can result inpotentially dangerous undesired fluid flow. For example, if the elongatebody extends too far and passes through the ventricular wall of theheart, fluid can be introduced into the space between the ventricle walland pericardial sac. Further, this kind of positioning error can becommon because the walls of the heart have varying thicknesses dependingon location. Being able to visualize the flow of fluid introduced intothe heart, liver, or other area of the body can allow for rapidrecognition of undesired fluid flow and enable subsequent remedial stepsto correct the flow and resume therapy.

By way of further example, undesired flow can occur even when theelongate body is correctly positioned in a volume of tissue due to thepresence of certain anatomical structures. Veins, capillaries, and othersources of blood flow, for example, can carry fluid introduced adjacentthereto away from the target treatment volume of tissue, therebypreventing the tissue in the target volume of tissue from being raisedto a therapeutic level. Directly visualizing the flow of fluidintroduced into the patient's body can alert a user to the presence ofsuch an anatomical feature quickly and allow for more rapid resumptionof therapy after repositioning or otherwise compensating for theadjacent blood flow (e.g., by increasing fluid temperature or flowrate).

All papers and publications cited herein are hereby incorporated byreference in their entirety. One skilled in the art will appreciatefurther features and advantages of the invention based on theabove-described embodiments. Accordingly, the invention is not to belimited by what has been particularly shown and described, except asindicated by the appended claims.

What is claimed is: 1.-22. (canceled)
 23. A system for delivering fluidenhanced ablation therapy, comprising: an elongate body having proximaland distal ends, an inner lumen extending through the elongate body, atleast one outlet port formed in the elongate body, and at least oneablation element positioned along the length of a distal portion of theelongate body; an imageable fluid source in communication with the innerlumen of the elongate body, the imageable fluid source including salineand a contrast agent; a heating element disposed within the inner lumenof the elongate body and configured to heat the imageable fluid totransform the imageable fluid into an imageable therapeutic fluid thatcan flow through the at least one outlet port and be delivered to tissuesurrounding the at least one ablation element.
 24. The system of claim23, wherein a heat capacity of the imageable fluid is greater than about2 J/ml-° C.
 25. The system of claim 23, wherein a ratio of the saline tothe contrast agent is about 1:1.
 26. The system of claim 23, wherein aratio of the saline to the contrast agent is about 10:1.
 27. The systemof claim 23, wherein a ratio of the saline to the contrast agent isabout 20:1.
 28. The system of claim 23, wherein the contrast agent isiohexol.
 29. The system of claim 23, wherein the ablation element isconfigured to deliver energy selected from the group consisting ofelectromagnetic energy, radio frequency energy, laser energy, microwaveenergy, and ultrasonic energy.